Manufacturing Specialist

2 weeks ago

Philadelphia, United States Planet Pharma Full time

Essential Functions and Responsibilities

  • Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
  • Lead teams investigating minor, major and critical nonconformances and deviations, including gathering information through structured root cause analysis. Draft and revise deviation reports as needed to assure that deviations are addressed in a timely manner.
  • Own and manage change controls associated with manufacturing areas and equipment.
  • Participate in technology transfer, conference calls and sharing of technical information.
  • Coordination of front-end document requests with supporting departments.
  • Assure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
  • Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
  • Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
  • Attends the weekly management meeting to discuss timelines and weekly priorities.
  • Contribute to projects to ensure timely initiation and completion of work.
  • May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
  • Troubleshoot issues and prioritize workload to solve moderately complex problems, including on the floor troubleshooting support as needed.
  • Ability to work in a team environment and independently as required. Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
  • Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements. Review data as generated/collected by less experienced technical staff.
  • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
  • Perform miscellaneous duties as assigned.


Travel

  • May require up to 10% travel, based on business need.


Required Education, Skills, and Knowledge

  • Minimum bachelor’s degree (B.A./B.S.) in biology, biochemistry, bioengineering, or related technical field, or equivalent industry experience.
  • Minimum of 2 years of experience in biopharmaceutical based GMP manufacturing operations.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Demonstrated strong technical knowledge of aseptic processing in cleanroom environments is a must.
  • Ability to build relationships quickly and credibly. Provide consistent, excellent support to staff, with the ability to influence large teams within the manufacturing department representing a variety of personalities and experience levels.
  • Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
  • Ability to deal with ambiguity – ready to change gears and plans quickly, with the need to manage constant change.
  • Ability to work successfully in a fast-paced, team-oriented environment.
  • Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Excellent presentation skills, both written and verbal.
  • Understands and complies with quality standards and requirements as documented.
  • Must have strong written and verbal communication and organizational skills.
  • Strong computer skills, problem solving and attention to detail.
  • Familiarity with data and sample management required (LIMS/MES)
  • Able to work independently with minimal supervision.
  • Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics.
  • This position is currently for regular work week hours (1st shift M-F)
  • Need to be able to read, write and understand English, and be proficient in Microsoft (Excel, Word, Outlook).

  • Biotherapeutics Manufacturing Technical Specialist

    4 weeks ago

    Philadelphia, Pennsylvania, United States Planet Pharma Full time

    Job Title:Biotherapeutics Manufacturing Technical SpecialistJob Summary:We are seeking a highly skilled Biotherapeutics Manufacturing Technical Specialist to join our team at Planet Pharma. The successful candidate will have a strong background in cell culture and aseptic technique, with expertise in manufacturing process tech transfer. As a key member of...

  • Manufacturing Operations Specialist

    4 days ago

    Philadelphia, Pennsylvania, United States R&D Partners Full time

    At R&D Partners, we're looking for a skilled Manufacturing Operations Specialist to join our team.This role is a key part of our manufacturing operations and will be responsible for supporting documentation, leading teams in investigating nonconformances, managing change controls, and participating in technology transfer.The ideal candidate will have a...

  • Manufacturing Specialist

    3 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Manufacturing Specialist needed!Essential Functions and Responsibilities:Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.Lead teams investigating minor, major and critical nonconformance's and deviations, including gathering...

  • Manufacturing Specialist

    2 weeks ago

    philadelphia, United States Planet Pharma Full time

    Manufacturing Specialist needed!Essential Functions and Responsibilities:Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.Lead teams investigating minor, major and critical nonconformance's and deviations, including gathering...

  • Manufacturing Specialist

    2 weeks ago

    philadelphia, United States Planet Pharma Full time

    Manufacturing Specialist needed!Essential Functions and Responsibilities:Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.Lead teams investigating minor, major and critical nonconformance's and deviations, including gathering...

  • Manufacturing Specialist

    2 months ago

    Philadelphia, United States Planet Pharma Full time

    615374 Manufacturing SpecialistDirect HirePhiladelphia, PAEssential Functions and ResponsibilitiesSupport documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.Lead teams investigating minor, major and critical nonconformances and deviations,...

  • Sheet Metal Fabrication Specialist

    20 minutes ago

    Philadelphia, Pennsylvania, United States Amuneal Manufacturing Corp Full time

    About Amuneal Manufacturing CorpAmuneal Manufacturing Corp is a leading manufacturer of precision sheet metal parts and assemblies. With nearly 60 years of experience, we operate two divisions in Philadelphia, each focused on delivering high-quality products through exploration, research, investment, and skilled craftsmanship.We are seeking highly skilled...

  • Manufacturing Specialist

    4 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Essential Functions and Responsibilities Support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.Lead teams investigating minor, major and critical nonconformance's and deviations, including gathering information through structured root...

  • Manufacturing Associate

    1 week ago

    Philadelphia, United States Proclinical Staffing Full time

    Manufacturing Associate - Contract - Philadelphia, PAProclinical is working alongside a CMO company seeking a Manufacturing Associate for a contract role in Philadelphia, PA. This position focuses on supporting gene therapy manufacturing processes within a Contract Manufacturing Organization (CMO). The role requires attention to detail, adherence to...

  • Aseptic Manufacturing Training Supervisor

    3 days ago

    Philadelphia, United States R&D Partners Full time

    Job DescriptionJob DescriptionThe Training Specialist Supervisor will oversee Training Specialists within the Manufacturing Training Department. This position will play a pivotal role in overseeing and executing training programs for the aseptic manufacturing team. This individual will ensure that all manufacturing personnel are...

  • Manufacturing Engineer

    3 hours ago

    Philadelphia, Pennsylvania, United States Revel Staffing Full time

    Job OverviewThe Revel Staffing team is seeking a skilled Manufacturing Engineer - CNC Program Specialist to join our network of professionals. As a key member of our team, you will be responsible for providing engineering support for CNC machines.About the RoleThis exciting opportunity involves generating CNC programs, setting up machines, and ensuring...

  • MSAT Specialist

    1 month ago

    Philadelphia, United States Planet Pharma Full time

    MSAT SpecialistOverviewThe MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Specialist reports to the Senior Manager, MSAT and EM and is responsible for manufacturing data analysis, contributing to deviation root cause analysis, and owning steps of the manufacturing process tech transfer. The MSAT Specialist is also...

  • MSAT Specialist

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Open to level I/Sr. MSAT Specialist candidate.OverviewThe MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Specialist reports to the Senior Manager, MSAT and EM and is responsible for manufacturing data analysis, contributing to deviation root cause analysis, and owning steps of the manufacturing process tech...

  • Senior MSAT Specialist

    2 weeks ago

    philadelphia, United States Planet Pharma Full time

    Sr. MSAT Specialist (2nd shift) needed!Overview:The Senior MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Senior Specialist reports to the Director, MSAT and is responsible for manufacturing data analysis, contributing to deviation root cause analysis and owning steps of the manufacturing process tech transfer. The...

  • Senior MSAT Specialist

    2 weeks ago

    philadelphia, United States Planet Pharma Full time

    Sr. MSAT Specialist (2nd shift) needed!Overview:The Senior MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Senior Specialist reports to the Director, MSAT and is responsible for manufacturing data analysis, contributing to deviation root cause analysis and owning steps of the manufacturing process tech transfer. The...

  • Senior MSAT Specialist

    2 weeks ago

    Philadelphia, United States Planet Pharma Full time

    Sr. MSAT Specialist (2nd shift) needed!Overview:The Senior MSAT Specialist is a Manufacturing Operations cell therapy subject matter expert. The MSAT Senior Specialist reports to the Director, MSAT and is responsible for manufacturing data analysis, contributing to deviation root cause analysis and owning steps of the manufacturing process tech transfer. The...

  • Cell Manufacturing Technician

    2 weeks ago

    Philadelphia, United States Proclinical Staffing Full time

    Cell Manufacturing Technician - Contract - Philadelphia, PAProclinical is seeking a dedicated Cell Manufacturing Technician to join a dynamic team. Primary Responsibilities:The successful candidate will be required to focus on executing cell therapy manufacturing processes, maintaining quality standards, and supporting operational functions. This position...

  • Materials Handler

    4 weeks ago

    Philadelphia, United States Amuneal Manufacturing Full time

    At Amuneal, each product we create is influenced by exploration, research, investment, and a never-ending focus on the highest quality materials, cutting-edge technologies, and skilled craftsmanship. With nearly 60 years of experience, Amuneal operates two divisions in Philadelphia, each with a focus on the highest quality products, fed by a strategy focused...

  • Proclinical Staffing | Manufacturing Associate | philadelphia, pa

    1 week ago

    philadelphia, United States Proclinical Staffing Full time

    Manufacturing Associate - Contract - Philadelphia, PAProclinical is working alongside a CMO company seeking a Manufacturing Associate for a contract role in Philadelphia, PA. This position focuses on supporting gene therapy manufacturing processes within a Contract Manufacturing Organization (CMO). The role requires attention to detail, adherence to...

  • Proclinical Staffing | Manufacturing Associate | philadelphia, pa

    1 week ago

    philadelphia, United States Proclinical Staffing Full time

    Manufacturing Associate - Contract - Philadelphia, PAProclinical is working alongside a CMO company seeking a Manufacturing Associate for a contract role in Philadelphia, PA. This position focuses on supporting gene therapy manufacturing processes within a Contract Manufacturing Organization (CMO). The role requires attention to detail, adherence to...